Trial of KPT-330 in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL)
- Conditions
- Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)Relapsed or Refractory Cutaneous T cell Lymphoma (CTCL)Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
- Registration Number
- ACTRN12614001328662
- Lead Sponsor
- Karyopharm Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 30
1. Adult patients 18 years of age or older and providing informed consent
2. ECOG performance status of less than or equal to 2.
3. Relapsed or refractory to previous treatment of PTCL/CTCL
4. Acceptable organ function
5. Non pregnant or not breastfeeding
1. Known active central nervous system (CNS) lymphoma.
2. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (except glucocorticoids) less than 4 weeks prior to Cycle 1 Day 1, and radio-immunotherapy 6 weeks prior to Cycle 1 Day 1.
3. Have not adequately recovered from the side effects of previous antineoplastic agents prior to dosing.
4. Active graft-versus-host disease after allogeneic stem cell transplantation.
5. Autologous stem cell transplantation less than 100 days prior to Cycle 1 Day 1
6. Concurrent therapy with approved or investigational anti-cancer drugs
7. Major surgery within last 2 weeks
8. Any other significant concomitant illness
9. Unstable cardiovascular function
10. Uncontrolled infection
11. Active HIV or hepatitis infection
12. Serious psychiatric or medical condition
13. Unable to swallow capsules
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine selinexor overall disease response rate.<br><br>For PTCL patients, disease response will be evaluated by scheduled PET-CT /PET/MRI scans and tumour measurements every 8 weeks.<br><br>For CTCL patients, disease response will be assessed using physical examination and skin assessment every 4 weeks.[For PTCL patients- Every 8 weeks until disease progression or death <br><br>For CTCL patients - Every 4 weeks until disease progression or death ]
- Secondary Outcome Measures
Name Time Method